Back in January of 2000, the manufacturer St. Jude voluntarily recalled its Silzone mechanical heart valves. St. Jude did not think it necessary for patients to undergo surgery to replace the valves. There were 36,000 Silzone valves implanted through out the world, with hundreds implanted into patients in the Atlanta Metropolitan area.
Mechanically, the St. Jude valves were seemingly all right. Therefore, the problem was not with the functioning ability of the valve but the problem was with the coating on areas of the valve. Silver was used in the making of the Silzone so to lessen the chance of infection. However, the silver reportedly leaked, which could have caused heart failure.
Additionally, in a trial called the Artificial Valve Endocarditis Reduction Trial (AVERT) an increased risk of stroke was reported. Though the chance of stroke is relatively low, the study did find a higher incidence of paravalvular leakage in patients with the valve implant.
A study was conducted on patients with the St. Jude Silzone valve in 2003 and was published in the journal Heart. The study tried to determine adverse effects the valves have had on patients. Researchers found that patients with the Silzone mitral valve didn’t have too much paravalvular leakage, but the study did find that the patients have a higher rate of early postoperative embolism.
A lawsuit was filed against St. Jude over the Silzone heart valve. And a settlement was reached between the members of the class action suit and St. Jude in 2009. Patients who had the implant and experienced problems and patients who had the implant and did not experience problems received awards.